Saxagliptin Impurity 57

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For Research Use Only | Not For Clinical Use

CAT	APB125347833
CAS	125347-83-3
Molecular Weight	243.3
Molecular Formula	C12H21NO4

What is the molecular weight of Saxagliptin Impurity 57?

The molecular weight of Saxagliptin Impurity 57 is 243.3.

What is the molecular formula of Saxagliptin Impurity 57?

The molecular formula of Saxagliptin Impurity 57 is C12H21NO4.

What is the CAS number of Saxagliptin Impurity 57?

The CAS number of Saxagliptin Impurity 57 is 125347-83-3.

Can Saxagliptin Impurity 57 be used as an active pharmaceutical ingredient (API)?

Saxagliptin Impurity 57 is not typically used as an API but ra- Ther considered an impurity in the synthesis or production of the drug saxagliptin.

What is the role of impurities like Saxagliptin Impurity 57 in drug synthesis?

Impurities like Saxagliptin Impurity 57 are unwanted substances that can potentially affect the safety, efficacy, and quality of the drug product. therefore, monitoring and controlling impurities are essential in drug synthesis.

How can Saxagliptin Impurity 57 be detected and quantified in a pharmaceutical formulation?

Saxagliptin Impurity 57 can be detected and quantified using analytical techniques such as high-performance liquid chromatography (HPLC) or mass spectrometry.

What are some potential sources of Saxagliptin Impurity 57 in the manufacturing process?

Saxagliptin Impurity 57 can be formed as a byproduct during the synthesis of saxagliptin or due to degradation of the drug substance under certain conditions.

What are the potential risks associated with high levels of Saxagliptin Impurity 57 in a drug product?

High levels of Saxagliptin Impurity 57 in a drug product can lead to decreased potency, decreased shelf life, and potential toxicity.

How can the presence of Saxagliptin Impurity 57 impact the regulatory approval of a drug product?

The presence of Saxagliptin Impurity 57 above acceptable limits can raise concerns during regulatory review and may result in delays or rejection of approval.

What measures can be taken to minimize the formation of Saxagliptin Impurity 57 during drug synthesis?

Process optimization, use of appropriate reaction conditions, and implementation of quality control measures are some ways to minimize the formation of Saxagliptin Impurity 57 during drug synthesis.

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